At Elanco (NYSE: ELAN) it all starts with animals!
As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. We re driven by our vision of Food and Companionship Enriching Life and our approach to sustainability the Elanco Healthy Purpose to advance the health of animals, people, the planet and our enterprise.
Making animals lives better makes life better join our team today!
Company Overview:
At Elanco (NYSE: ELAN) it all starts with animals!
As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. We re driven by our vision of Food and Companionship Enriching Life and our approach to sustainability the Elanco Healthy Purpose to advance the health of animals, people, the planet, and our enterprise.
At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.
Making animals lives better makes life better join our team today!
Your Role: [Associate/ Senior Associate Manager Aggregate Report Writing]
As an Associate/ Senior Associate Manager Aggregate Report Writing, you will be part of Global Pharmacovigilance team to deliver veterinary pharmacovigilance documents for regulatory submission and internal use. The purpose of this role is to ensure the provision of comprehensive, high quality, scientifically accurate and consistent medical information in consultation with the Global Pharmacovigilance team.
Your Responsibilities:
- Author/review of routine regulatory documents including, but not limited to aggregate reports (PSURs, PDER), Annual Signal Management Reports, and literature searches and occasionally other regulatory documents such as Risk Management Plan, Benefit-Risk Evaluation reports and Ad hoc PSURs required in accordance with applicable regulatory requirements.
- Provide oversight to co-authors or team of writers as applicable and be accountable for the quality of their work/contributions.
- Support Regulatory Affairs team in the timely submission of Regulatory dossier for the initial or renewal of product registrations.
- Maintaining and completing Veeva Vault RIM tasks on time.
- Collaborate with regulatory affairs, quality assurance, and clinical teams to gather relevant data and ensure consistency. Liaise with global affiliates, and regulatory authorities when necessary.
- Ensure documentation and processes are audit-ready and support regulatory inspections when applicable.
- Participate in training and continuous improvement activities related to pharmacovigilance and PSUR processes.
What You Need to Succeed (minimum qualifications):
- Education : i. e. Graduation in veterinary medicine/ post-graduation in pharmacy or any other life science background.
- Experience : A minimum of 3 - 5 years of industry experience in PV or medical writing.
- Excellent oral and written communication skills with ability to communicate logically and technically with global stakeholders.
- High competency in Microsoft Office applications.
- In-depth knowledge of GxP requirements and regulatory guidelines with sound understanding of operational Regulatory and R&D principles.
What will give you a competitive edge (preferred qualifications):
- Ability to work independently or as part of a team and collaborate with global teams cross geographies and time zones.
- Experience with electronic document management systems (e. g. , Veeva Vault), Mastery of templates, styles, and submission-ready formatting.
Additional Information:
- Travel percentage up to 10%, annually.
- Location: IN, Bangalore - Hybrid Work Environment
Don t meet every single requirement? Studies have shown underrecognized groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but dont necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!
Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status
